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OpenTrials
Completed

NCT Number: NCT04714229

Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine

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Key information

Conditions

Infection, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects 19 to 55 years of age
  • Written informed consent
  • Available for all visits and telephone calls scheduled for the study

Exclusion criteria

  • Previous or suspected disease caused by N. meningitidis
  • Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
  • Serious acute, chronic or progressive disease as determined by investigator
  • History of alcohol or substance abuse

Treatment and study plan

Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine

Biological

0.5mL single intramuscular dose on Day 0

Other names: EuMCV4

Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine

Biological

0.5mL single intramuscular dose on Day 0

Other names: Menveo

Primary outcomes

  1. Occurrence of solicited adverse events

    Time frame: within 7 days post vaccination

    local and systemic AEs

  2. Occurrence of unsolicited adverse events

    Time frame: within 28 days post vaccination

  3. Occurrence of serious adverse events

    Time frame: within 180 days post vaccination

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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